Page 1 Peer Review of NIH Research Grant Applications Anthony M. Coelho, Jr., Ph.D. Review Policy Officer Office of the Director NIH Office of Extramural Research Anthony M. Coelho, Jr., Ph.D. Experience: Review Policy Officer Chief - Clinical Studies and Training Section NIHBI and Scientific Review Administrator Peer Reviewer Funded Investigator (NIH, DOE, EPA and Private Sector Funding) 5 years 7 years 12 years 18 years
Page 2 Important Things to Know: 1. The handout material is a reference resource 2. The handout contains more information than I will discuss 3. Information that is important is repeated to remind you that it is important Important Things to Know: NIH Peer Review Process based on Laws NIH Peer Review Practices based on Culture and Behavior of Study Section Culture My objective is to help you understand both
Page 3 The NIH View: The Research Partnership NIH Applicant Institution Review Administrator Program Administrator Principal Investigator Authorized Institutional Official Grants Management Administrator Sponsored Research Administrator The Applicant View: Office of the Director * National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of General Medical Sciences $ National Institute National Institute NIH of Dental and $ of Diabetes and National Institute National Institute Craniofacial Digestive and on Drug Abuse of Environmental Research Kidney Diseases National Institute National Heart, National Human National Institute of Neurological Lung, and Blood Genome Research of Mental Health Disorders and Institute Institute Stroke National Eye Institute National Institute of Nursing Research National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities Clinical Center Center for Information Technology Center for Scientific Review No funding authority
Page 4 NIH 2005 Budget 28+ Billion ~26 Billion for Research Rule #1 DO NOT write the application for Yourself unless you are going to fund it yourself You MUST convince the entire review committee and the funding agency
Page 5 Inside the box Office of the Director * National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities Clinical Center Center for Information Technology Center for Scientific Review No funding authority Rule #2 STUDY SECTIONS DO NOT FUND! INSTITUTES FUND!
Page 6 Rule #3 You must satisfy the needs of reviewers and the needs of the funding agency Applying for Funding NIH
Page 7 Offices at NIH NIH The wrong way to request funds NIH Send $$
Page 8 Response to the wrong form of request Correct Way to request Funds
Page 9 PHS Research Grant Application Kit (form PHS 398) Electronic Forms and Instructions Great Expectations + = NOBEL Prize Dr. Me
Page 10 Peer Review + + NOBEL Prize Dr.Me Response to Unsuccessful Peer Review NOBEL Prize Dr. Me
Page 11 NIH GRANT$ Formula for Grant Success Elements of Grant Success Good Ideas Good Timing Good Presentations Good Reviewers Good Luck Good Grantsmanship
Page 12 Good Grantsmanship *Knowing + Understanding What to do How to do it When to do it What to do when things don t go as planned *Being willing to do what is needed Passion and Commitment *Doing it- doing what is needed Commitment * Understanding Peer Review The other method of applying for grant funds
Page 13 Understanding NIH Peer Review
Page 14 Simple Model of the NIH Review Process for a Research Grant Revise & Resubmit Application N I H Referral Review Program Not Funded Grant Award $ Principal Investigator REVIEW PROCESS FOR NIH RESEARCH GRANTS National Institutes of Health Research Grant Application (PI) Principal Investigator Initiates Research Idea School or Other Research Center (Applicant) Submits application Center for Scientific Review Assign to IC and SRG Scientific Review Group Review for Scientific Merit Institute Evaluate for Relevance Conducts Research Allocates Funds $$ Advisory Council or Board Recommends Action Institute Director Takes final action for NIH Director
Page 15 Dual Review System for Grant Applications First Level of Review Scientific Review Group (SRG) Provides Initial Scientific Merit Review of Grant Applications Rates Applications and Recommends for Level of Support and Duration of Award Second Level of Review Advisory Council Assesses Quality of SRG Review of Grant Applications Makes Recommendation to Institute Staff on Funding Evaluates Program Priorities and Relevance Advises on Policy STUDY SECTIONS JUDGE Scientific and Technical Merit Institute staff use the evaluations as part of the process of considering the relevance of applications to the Institute s mission, research priorities and portfolio of existing research STUDY SECTIONS DO NOT FUND! INSTITUTES FUND!
Page 16 Grant Application Receipt and Assignment Applications Submitted to NIH Approximately 65,000+ grant applications are submitted to NIH each year, 25-30% are funded Competing grant applications are received for three review cycles per year
Page 17 Timeline Submission Review Post-Review Phase Oct 1/Nov 1* 03 Feb Mar 04 Mar- Jun 04 May/Jun 04 Jul 1 04 Feb 1/Mar 1* 04 Jun Jul 04 Sep 30 04 Sep/Oct 04 Dec 1 04 Jun 1/Jul 1* 04 Oct Nov 04 Nov- Feb 05 Jan/Feb 05 Apr 1 05 Standard Receipt Date (new/ *revised and continuation) Initial Peer Review Funds Released for Payline Grants Chosen for Expedited Second- Level Review Council Meeting; Anticipated Funding Approved Award for Nonexpedited and Special Action Awards Receipt Dates * ** Depend on the Type of Application Jan, May, Sept 10: Institutional Training Grant Jan, May, Sept 25: Academic Research Enhancement Award Mar, Jul, Nov 1: Revised, Competing Continuations, and Supplements April, Aug, Dec 1: Small Business Technology Transfer April, Aug, Dec 5: Individual NRSA April, Aug, Dec 1: Small Business Innovation Research May, Sept, Jan 1: AIDS * RFA and RFP dates defined in the solicitations ** ALWAYS check with Institutes to verify dates
Page 18???? What Happens To Your Application When It Arrives at NIH???? Mail room 1
Page 19 Center for Scientific Review (CSR) Focal Point for Receipt and Referral Central receipt point for PHS applications Referral to Institutes (Funding Components) and to Study Sections (Review Components) CSR study sections reviews of most investigator initiated research and research training applications for scientific merit Assignment to CSR Study Sections Applications assigned to study sections known as Scientific Review Groups (SRG) based on: 1. specific referral guidelines for each SRG and 2. information contained in your application (Go to the Website http://era.nih.gov/roster/index.cfm to learn about study sections their scientific mission and their scientific membership)
Page 20 WHO/WHAT DETERMINES WHICH GROUP REVIEWS THE APPLICATION? Mechanism Type of application CSR or Institute Review Referral and Review Staff Past Review History (if any) of application Principal Investigator Letter attached to application; self-referral Peer Review of NIH Support Mechanisms Who Reviews What? CSR Institutes Research Project Grant (R01) Program Project Grant (P01) Postdoctoral Fellowship (F32) Center Grant (P30, P50, P60) Senior Fellowship (F32) Institutional Fellowship (T32) Fogarty International Center Academic Career Award (K07) Fellowship (F05, F06) Mentored Clinical Scientist Short-Term Training (T35) Development Award (K08) Small Business Grants (R41, R42 Conference Grant (R13)* R43, R44) Marc Fellowships (F34, F36, T34) Academic Research Enhancement Minority Biomedical Support Award (R15) Grant (S06) Biomedical Research Support Resource Grant (P40, P41, R24, Shared Instrumentation R26, R28) Grant (S10) RFA - Request for Applications R&D - Contracts
Page 21 WHO/WHAT DETERMINES WHICH GROUP REVIEWS THE APPLICATION? YOU DO! The words that are in your application Your title Your abstract Your specific aims Your methods Sample Application Number Individual Serial Amended Research Number Grant 1 R01 CA 123456 01 A1 New National Grant Application Cancer Support Institute Year
Page 22 Assignment Notification Letter Dear Dr. Sample: Your grant application entitled CEREBRAL VESSEL INNERVATION IN HYPERTENSION has been received by the National Institutes of Health and assigned to a Scientific Review Group (SRG) for scientific merit evaluation and to an Institute/Center for funding consideration. Specific information about your assignment is given below. The initial peer review should be completed by March, 2001, and a funding decision made shortly after the appropriate National Advisory Group meets in May, 2001. Questions about the assignment should be directed to the Scientific Review Administrator (SRA) or the Division of Receipt and Referral, Center for Scientific Review at (301) 435-0715. Other questions prior to review should be directed to the Scientific Review Administrator and questions after the review to the program staff in the Institute/Center. Assignment Notification Letter (continued) Principal Investigator: Sample Pamela Assignment Number: 2 R01 HL12345-12A1 Dual Assignment: NS Scientific Review Group: Epidemiology and Disease Control Subcommittee 2 SS (EDC2) A roster of the membership of this Scientific Review Group located on the following website: http://era.nih.gov/roster/index.cfm
Page 23 Assignment Notification Letter (continued) Scientific Review Administrator: DR. DAVID MONSEES, SRA CTR FOR SCIENTIFIC REV 6701 ROCKLEDGE DR RM 3199 MSC7802 BETHESDA MD 20892 (301) 435-0684 Assigned Institute/Center: NATL HEART, LUNG, & BLOOD INST DIV/EXTRAMURAL AFFAIRS RK2 7100 NATIONAL INSTITUTES OF HEALTH BETHESDA, MD 20892 (301) 480-5295 Assignment Notification Letter (continued) IMPORTANT NOTICE: Please review the information on human and animal subjects research located at: http://grants.nih.gov/grants/peer/hum_anim_notice.pdf as these requirements will affect the priority score on your application.
Page 24 Study Section Meeting: Scientific Review Groups TYPES OF REVIEW COMMITTEES: Chartered Study Sections when the subject matter of the application matches the referral guidelines for the standing study section Special Emphasis Panels (SEPs) when the subject matter does not fit into any study section, or when assignment of an application to the most appropriate study section would create a conflict of interest, or Special Mechanisms (RFA, Fellowships, SBIRs, AREAS, etc.)
Page 25 Study Sections at NIH Study Sections are managed by a Scientific Review Administrator (SRA) who is a professional (at Ph.D. or MD level) whose scientific background is close to the expertise of the study section Each standing study section has 12-24 members who are primarily from academia 60-100 applications are reviewed at each study section meeting Several hundred study section meetings Special Emphasis Panels vary in size and number of applications that they review per meeting SCIENTIFIC REVIEW GROUP Scientific Review Administrator Recruits and selects reviewers Insures that the review that is competent, thorough and fair (unbiased) Proper review criteria used to evaluate application Reviewers Some charter members; some temporary members Scientists with appropriate expertise High professional profiles Dependable, reasonable, open minded Grants Technical Assistant Mails material to reviewers Handles paperwork Organizes meeting room Enters scores and codes Assists with summary statements
Page 26 Center for Scientific Review Example of Varied Expertise on a Sample Study Section Surgery, Anesthesiology and Trauma Study Section Selected Areas of Competence of Members Biochemistry Burn Physiology and Electrolyte Metabolism Cardiovascular and Pulmonary Physiology Clinical Anesthesiology Drug Metabolism (Anesthetics) General Surgery Immunology and Transplantation Nutrition Pharmacology (Analgesics, Narcotics and Antagonists) Pulmonary Embolism Shock and Trauma Toxicology of Anesthetic Drugs Vascular Surgery WHO ASSIGNS REVIEWERS TO MY APPLICATION? Scientific Review Administrator Assignment to Specific Reviewers Based on application content Based upon expertise of reviewers Based upon knowledge of the field May consult with Institute staff May consult with chairperson Suggestions from PI on type of expertise needed to evaluate (NEVER names) Considers review history
Page 27 Criteria For Selection of Peer Reviewers Demonstrated Scientific Expertise Doctoral Degree or Equivalent Mature Judgment Work Effectively in a Group Context Breadth of Perspective Impartiality Interest in Serving Adequate Representation of Women and Minority Scientists Certification of No Conflict of Interest This will certify that in the review of applications and proposals by (study section) on (date), I did not participate in the evaluation of any grant or fellowship applications from (1) any organization, institution or university system in which a financial interest exists to myself, spouse, parent,child, or collaborating investigators; (2) any organization in which I serve as officer, director, trustee, employee or collaborating investigator; or (3) any organization which I am negotiating or have any arrangements concerning prospective employment or other such associations. SIGNATURES
Page 28 Confidentiality Review materials and proceedings of review meetings represent privileged information to be used only by consultants and NIH staff. At the conclusion of each meeting, consultants will be asked to destroy or return all review-related material. Consultants should not discuss review proceedings with anyone except the SRA. Questions concerning review proceedings should be referred to the SRA. WHAT HAPPENS IN A STUDY SECTION MEETING? Closed to the public (FACA rules apply) Orientation Conflict of interest Developments of interest to the study section Changes in policy or procedure Introduction of persons present Role of persons present Streamlining or list provisionally approved Application by application discussion Persons with conflicts of interest excused Assigned reviewers give preliminary scores Discussion of application s scientific and technical merit Assigned reviewers first, then other members Range of scores set Every member scores every application * Assignment of gender, minority, and children codes, human subjects codes; recommended changes to budget
Page 29 WHAT IS STREAMLINING? Process by which reviewers judge which applications are in the lower half of those assigned for review. Applications in the lower half are evaluated by the reviewers prior to attending the meeting but they are not discussed at the Scientific Review Group meeting. Any member can object to the streamlining of an application Requires that all reviewers agree to streamline an application Streamlined applications receive written reviewer critiques Why? Shortens meetings Reviewers more willing to serve on committee Allows more time for discussion of applications Review of Applications Applications are not reviewed at the meeting. They are evaluated prior to the meeting. The meeting is a time for discussion and negotiation of a priority score and for making a recommendation that best reflects the scientific and technical merit of the application. Strong applications get brief discussion Weak application get brief discussion Marginal application get longer discussion to ensure fairness to the applicant
Page 30 Review of Research Grants REVIEW CRITERIA: Significance Approach Innovation Investigator Environment Described in detail in the PHS 398 application instructions Review Criteria Significance: Does the study address an important problem? How will scientific knowledge be advanced? Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? Innovation: Are there novel concepts or approaches? Are the aims original and innovative? Investigator: Is the investigator appropriately trained? Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?
Page 31 Newly Revised Review Criteria 1. Significance Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 2. Approach Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation Is the project original and innovative? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? 4. Investigators Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? 5. Environment Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Research Involving Human Subjects Important Considerations that must be addressed in the application because they impact on priority score - considered to be part of the Approach Are there any risks* to the human subjects? Are the protections adequate? Are there potential benefits to the subjects and to others? What is the importance of the knowledge to be gained? Are the plans for inclusion of minorities, both genders and children adequately addressed? Is the proposed study exempt from human subject review? No page limits * Risks include the possibility of physical, psychological, or social injury resulting from research.
Page 32 Research Involving Human Subjects Areas of exemption Education Research normal educational practices Educational Tests, Survey or Interview Procedures, or Observation of Public Behavior subjects not identified subjects privacy rights protected Educational Tests, Survey or Interview Procedures, or Observation of Public Behavior Not Exempt in Previous Category if: subjects are public officials or public office candidates federal statute requires confidentiality without exception Research Involving Human Subjects Areas of exemption Collection or Study of Existing Data, Documents, Records, Pathological Specimens information publicly available subjects not identified Research and Demonstration Projects Regarding Certain Public Benefit or Service Programs Taste and Food Quality Evaluation and Consumer Acceptance Studies Using foods without additives U.S. Government approved food ingredient
Page 33 Inclusion of Women and Minorities in Clinical Research Women and Minorities must be considered for inclusion in all clinical research supported by NIH or Appropriate justification must be provided to explain why they are not included in the proposed research Research Involving Children Children must be considered for inclusion in all human subject research supported by NIH or Appropriate justification must be provided to explain why they are not included in the proposed research
Page 34 Research Involving Children Children must be considered for inclusion in all human subject research supported by NIH Effective for all new applications received after October 1, 1998 Child is defined as an individual under age 21 If children are included, Investigator must address age range expertise of investigative team facilities sufficient numbers Research Involving Children If children are not included, must justify exclusion: Topic irrelevant to children Laws/regulations bar inclusion of children Knowledge already available or being obtained Separate study warranted Unable to judge potential risk to children Collecting data on pre-enrolled adults Other special cases
Page 35 Vertebrate Animals Important Considerations Will the anticipated results be for the good of society? Will the work be planned and performed by qualified scientists? Will the animals be treated so as to avoid any unnecessary discomfort, pain, anxiety, or poor health? Species chosen? Animals in short supply? Scientific Review Group or Study Section Actions Scored, Scientific Merit Rating Priority scores: 1 (best) to 5 (poorest) and percentiles Unscored (lower half) Deferral
Page 36 Summary Statement After the review meeting is finished, the results are documented by the SRA in a summary statement and forwarded to the PI and to the assigned NIH Institute. The assigned NIH Institute is responsible for making a funding decision. The summary statement contains: Overall Resume and Summary of Review Discussion Essentially Unedited Critiques of Assigned Reviewer Priority Score and Percentile Ranking Budget Recommendations Administrative Notes National Advisory Council or Board Review
Page 37 Council Actions Assesses Quality of SRG Review Concurs with study section action or Modifies SRG (study section) action Can not change priority score Deferral for re-review of the same application no changes allowed Makes Recommendation to Institute Staff on Funding, Evaluates Program Priorities and Relevance and Advises on Policy NIH Policy does NOT allow Rebuttal of Peer Review outcome There is an Appeal process however Differences of Scientific Opinion Can NOT be Appealed! NIH policy permits appeal of review outcome if 1. Procedural error in review process 2. Factual errors (not differences of interpretations or understanding)
Page 38 REVISE & RESUBMIT Do Not Appeal Review Outcome NIH Appeal Outcomes: 1. Council Denies Appeal (bad outcome) 2. Council Accepts Appeal: Original Application and Letter of Appeal is sent to the Same Study Section for a second examination and evaluation (bad outcome) 3. Council Accepts Appeal: Original Application be sent to a new Study Section but without the Letter of Appeal (bad outcome) Timeline Consequences Best Way Revision Appeal Submit Feb 04 Feb 04 Feb 04 Review June 04 June 04 June 04 Council Sept 04 Sept 04 Sept 04 Earliest award Dec 04 Review 2 Oct 04 Council 2 Jan 05 Earliest Resubmission March05 Earliest Award Apr 05 Review 2 June 05 Earliest Resubmission July 05 Council 2 Sept 05 Review 3 Oct 05 Earliest Award Dec 05 Council Feb 06 Earliest Award June 06
Page 39 What Determines Which Awards Are Made? Scientific merit + Program Considerations + Availability of funds You do not want a reviewer to make this comment about your application: This application is characterized by ideas that are both original and scientifically important. Unfortunately the ideas that are scientifically important are not original and the ideas that are original are not scientifically important.
Page 40 You do not want a reviewer to make this comment about your application: In addition to proposing a research design that is a fishing expedition, the applicant also proposes to use every type of bait and piece of tackle ever known to mankind. The research that you propose in your application must be innovative and focused
Page 41 NIH Information Sources NIH GUIDE for Grants and Contracts U.S. Department of Health and Human Services Announces NIH Scientific Initiatives Provides NIH Policy and Administrative Information Available on the NIH Web Site : http://www.nih.gov http://grants.nih.gov/grants/guide/index.html
http://crisp.oit.nih.gov Page 42
Page 43 Learn the mission of the study section! Learn the membership of the study section!
Page 44 Learn about special funding opportunities! Learn about special funding opportunities!
Page 45 Program Announcements are very important for you Invites grant applications in a given research area May describe new or expanded interest in a particular extramural program May be a reminder of a continuing interest in a particular extramural program Generally has no funds set aside Applications reviewed in CSR along with unsolicited grant applications Requests for Applications (RFA) are very important for you Announcement describing an institute initiative in a well-defined scientific area Invitation to submit research grant applications for a one-time competition on a specific topic Set-aside of funds for a certain number of awards Applications generally reviewed within the issuing institute
Page 46 Selected Sites of Interest National Institutes of Health http://www.nih.gov Office of Extramural Research http://www.nih.gov/grants/oer.htm Grants Policy http://www.nih.gov/grants/policy/policy.htm NIH Study Section Rosters http://era.nih.gov/roster/index.cfm Office of Extramural Research: Grants Page http://grants1.nih.gov/grants/index.cfm Center for Scientific Review http://www.csr.nih.gov Referral and Review http://www.csr.nih.gov/refrev.htm Overview of Peer Review Process in CSR http://www. csr.nih.gov/review/peerrev.htm NIH Peer Review Notes http://www.csr.nih.gov/prnotes/prnotes.htm
Page 47 Office of Extramural Research Handles requests for grant applications, program guidelines, general information on grant applications and review policy Office of Extramural Research National Institutes of Health 6701 Rockledge Drive, Suite 6095 Bethesda, Maryland 20892-7910 PHONE: 301-435-0714 FAX: 301-480-0525 e-mail: grantsinfo@nih.gov NIH GRANT$ Formula for Grant Success
Page 48 Good Grantsmanship *Knowing + Understanding What to do How to do it When to do it What to do when things don t go as planned *Being willing to do what is needed *Doing it- doing what is needed Understanding Peer Review Thank You http://ora.stanford.edu/ora/ratd/nih_04.asp